One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors (ONE STOP)

February 27, 2024 updated by: Washington University School of Medicine

One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors (ONE STOP)

Stereotactic body radiotherapy (SBRT) has become a standard of care for medically inoperable or high-risk operable early-stage non-small cell lung cancer (NSCLC) patients. It is also increasingly used to treat lung metastases in patients with oligometastatic disease. While SBRT is a powerful tool for the treatment of lung tumors, access to specialized treatment can be limited for patients who live far away from a treatment center. Geographic accessibility can be limiting even for patients receiving one fraction lung SBRT, as the typical consult, CT simulation, and one-fraction treatment workflow is typically at least two to three weeks from start to finish, with a minimum of three in-person appointments.

In this study, a high-quality cone beam CT (CBCT) on-board imaging platform (HyperSight; Varian Medical Systems, Palo Alto, CA) will be coupled with advanced motion management and treatment techniques as well as Ethos (Varian Medical Systems, Palo Alto, CA) daily online adaptation to simulation-free workflow for one fraction SBRT. This has the potential to reduce the time it takes a patient to be cured of their lung tumor from two to three weeks to two to three hours. In this novel workflow, patients will undergo telephone/online consent followed by a diagnostic scan-based pre-plan for one fraction SBRT. On the morning of treatment, a brief follow-up appointment will be followed by treatment on the HyperSight/Ethos platform. Patients will be treated using a simulation-free workflow. A HyperSight Thorax Slow protocol CBCT will be acquired for study purposes, and then the patient will be treated with online adaptive CBCT-guided radiotherapy on the Ethos/HyperSight platform. Treatment delivery will take place following contouring and treatment planning. Patients will undergo standard of care simulation imaging in parallel for comparison.

The purpose of this study is to evaluate the feasibility of a ONE fraction Simulation-free Treatment with CT-guided stereotactic adaptive radiotherapy for Oligometastatic and Primary lung tumors (ONE STOP) workflow for patients with small, peripheral primary or oligometastatic lung tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pamela Samson, M.D., MPHS
  • Phone Number: 314-801-3806
  • Email: psamson@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Eric Laugeman, M.S.
        • Sub-Investigator:
          • Tianyu Zhao, Ph.D.
        • Contact:
        • Principal Investigator:
          • Pamela Samson, M.D., MPHS
        • Sub-Investigator:
          • Yi Huang, M.S.
        • Sub-Investigator:
          • Joshua Schiff, M.D.
        • Sub-Investigator:
          • Farmoush Forghani-Arani, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • One of the following diagnoses:

    • Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer .

      • Clinical AJCC stage I defined as stage 1A1 (T1a1N0M0, T1a tumor less than or equal to 1 cm), stage 1A2 (T1bN0M0, T1b tumor between 1 and 2 cm), and stage 1A3 (T1cN0M0, T1c tumor between 2 and 3 cm).
      • Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm.
      • Clinical AJCC stage IIA defined as T2bN0M0, T2b tumor between 4 and 5 cm.

    • Oligometastatic lung tumor secondary to a primary cancer of any type/histology. Oligometastatic patients may include patients with:

      • 1-5 sites of metastatic disease with at least one lung lesion intended to be treated with SBRT
      • More than 5 sites of metastatic disease with oligo-progressive disease in the lung intended to be treated with SBRT.

  • Lesions must be small and peripheral.

    • Small is defined as max tumor dimension of 5 cm or less.
    • Peripheral is defined as greater than 2 cm from the proximal bronchial tree/mediastinum.

  • Tumors and anatomy amenable to one-fraction lung SBRT confirmed by meeting of one-fraction lung SBRT target and constraint metrics on a diagnostic-scan based preplan.

    • Patients who do not meet this criterion will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.

  • Lesions must have a maximum superior to inferior motion of 1 cm on 4D-CT imaging.

    • Patients who do not meet this criteria will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.
  • At least 18 years of age.
  • Able to understand and willing to sign an IRB approved written informed consent.

Exclusion Criteria:

  • Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by ONE STOP SBRT.
  • Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of ONE STOP SBRT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One Fraction SBRT
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
Radiation: One fraction stereotactic body radiotherapy
Radiotherapy will consist of one-fraction SBRT using the Ethos linear accelerator and online adaptive treatment planning system.
Other Names:
  • SBRT
Device: HyperSight
HyperSight is a novel on-board imaging platform equipped with rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for both simulation and treatment.
Device: Ethos
Ethos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the ONE STOP workflow
Time Frame: Day 1

Feasibility is defined as the successful completion of the ONE STOP workflow through treatment delivery in at least 70% of patients.

Successful completion of the workflow is defined as ONE STOP plan creation and delivery of the fraction using the study workflow in one on-table attempt.

Unsuccessful completion of the workflow is defined as multiple attempts of the ONE STOP workflow for one patient without treatment delivery such that the study workflow is abandoned and a traditional one-, three-, or five-fraction plan is delivered.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Pamela Samson, M.D., MPHS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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